Breast Implant | Augmentation | US FDA Recommendations


US FDA Recommendations for Patients Who Have or Who Are Considering Breast Implants


  • Be aware that breast implants are associated with significant local complications, and the longer the devices remain implanted, the more likely you are to experience a complication. Local complications and adverse outcomes include capsular contracture, reoperation, removal, and implant rupture. Many women also experience breast pain, wrinkling, asymmetry, scarring, and infection.
  • Continue to receive routine follow-up with your physician. This includes having periodic MRI exams to detect “silent rupture” of the implant.
  • Notify your health care provider if you develop any unusual signs or symptoms including pain, asymmetry, hardness or swelling.
  • Recognize that breast implants are not lifetime devices. The longer you have your implants, the more likely it will be for you to have them removed.
  • If you have enrolled in an Allergan or Mentor post-approval study, continue to participate. These studies are the best way to collect information about the long-term rates of complications.
  • Continue routine screening mammography for breast cancer at intervals recommended by your health care provider based on your age and risk factors.

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